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Clinical Trials in China / NCT06814210
Starting soon Not applicable

CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair

NCT06814210 · tracked via the Priya Life Science China tracker
Sponsor
Xiao-dong Zhuang
Phase
Not applicable
Started
2025-03-01
Last updated
2025-02-07

Condition(s) studied

Mitral RegurgitationFunctional Mitral RegurgitationDegenerative Mitral Valve Regurgitation

Investigational drug(s) / intervention(s)

Cerebral Embolic Protection

Cerebral Embolic Protection: Subjects will undergo M-TEER following placement of the cerebral embolic protection device.

Study summary

Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices.

This prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Subjects must meet ALL of the following criteria: General Inclusion Criteria * Age ≥18 years * Severe Mitral Regurgitation (3+ to 4+) * Symptom status: NYHA functional class ≥ II * Subjects scheduled to receive the M-TEER per the current approved indications for use * Subjects agreed to join the study and complete follow-up Exclusion Criteria: Potential Subjects will be excluded if ANY of the following criteria apply: General Exclusion Criteria * Contraindication to MRI * CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days * Aortic or tricuspid valve disease requiring surgery or transcatheter intervention * COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use * Cerebrovascular accident within prior 30 days * Severe symptomatic carotid stenosis (\>70% by ultrasound) * Carotid surgery or stenting within prior 30 days * Hemodynamic instability requiring inotropic support or mechanical heart assistance * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. * Contraindication for transesophageal echocardiography * Life expectancy \< 1 year * Pregnant or planning pregnancy within next 12 months * Participation in another interventional Trial * Patients who are not able to give consent or complete the follow-up

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

More Xiao-dong Zhuang trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06814210 on ClinicalTrials.gov ↗ ← All trials in China